Brainlab RT Elements software recall for image cropping defect
Brainlab AG is recalling RT Elements software because large objects may display cropped during import, potentially affecting radiation treatment planning.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device software defect that could impact radiation treatment planning, representing a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Brainlab AG is recalling 48 systems of RT Elements software, specifically Adaptive Hybrid Surgery Analysis version 1.0.0. The software is used for radiation treatment planning in stereotactic, conformal, and computer-planned Linac-based treatments for cranial, head and neck, and extracranial lesions.
The recall is due to a defect where large objects with fine resolution are potentially displayed cropped when imported into the software. This issue could impact the evaluation of simulated plans used in tumor board meetings or operating rooms.
The affected software was distributed worldwide, including in the United States and internationally to Australia, Belgium, Brazil, Canada, China, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Mexico, Portugal, South Korea, Spain, Switzerland, Turkey, and the United Kingdom. Users should contact Brainlab AG for instructions on how to address the software defect.
The recalled product
- Product
- RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions. The simulated plan is intended for treatment evaluation for example in tumor…
- Manufacturer
- Brainlab AG
- Affected units
- 48
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Brainlab AG under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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